Introduction Opportunity Program Scope Process Requests for Support Evaluation Criteria Intellectual Property & Industrial Intervention Assessment & Oversight Metrics for Judging Success Additional Sources of Information FAQs Approved DCIDE Projects

Developing Medical Imaging Drug and Biological Products

• Part 1: Conducting Safety Assessments [PDF] (Issued 6/17/2004, Posted 6/17/2004)
• Part 2: Clinical Indications [PDF] (Issued 6/17/2004, Posted 6/17/2004)
• Part 3: Design, Analysis, and Interpretation of Clinical Studies [PDF] (Issued 6/17/2004, Posted 6/17/2004)

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF)

21 CFR Part 315 Diagnostic Radiopharmaceuticals

Center for Drug Evaluation and Research (CDER) Regulatory Information

• Exploratory IND Studies [HTML] or [PDF] (Issued 1/12/2006; Posted 1/12/2006)
• PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML ] or [PDF] (September 14, 2005)
• INDs - Approaches to Complying with CGMP during Phase 1 [HTML ] or [PDF] (January 9, 2006)
• CDER Guidances
• Radioactive Drug Research Committee (RDRC) Program

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

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